Hernandez 1

Melody Hernandez

Professor McClure

Writing 39C

10 June 2018

A Call to Morality: Abolishing Animal Experimentation

A survey conducted by the The United States Department of Agriculture’s Animal and

Plant Health Inspection Service in 2016 found that there has been a 15% increase in nonhuman

primate use for research, testing, or experimentation in the United States as seen in Figure 1.

Moreover, the USDA, has reported a total of 38,633 nonhuman primates bred and held captive

for future use in research and experimentation purposes (National). It is important to note that

nonhuman primates represented only 9% of animals protected under the Animal Welfare Act and

that were used for researched based purposes (USDA).

Figure 1. Nonhuman Primate Use in the U.S. for Research, Testing, and Teaching. ​National
Anti-Vivisection Society.

Ultimately, the need for animal experimentation for purpose of medical research has

increased throughout the years prompting the importance of the protection of the welfare of
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animals such as the rhesus macaques under regulations such as the Animal Welfare Act and its

several amendments. Thus, for the purposes of this paper it is important to note that throughout

the history animal testing for purposes such as medical research there have been two dominant

perspectives on this issue being Animal Rights versus Animal Welfare. Animal Rights or Animal

Liberation calls for the moral rights animals deserve. On contrary, the Animal Welfare differs

because it aims “to minimize the suffering of exploited animals but has not fundamentally

challenged the view that animals are essential resources” (​Animal​ 251). Although, this view is

concerned for the welfare of the animal it ultimately consists of decisions that benefit the human

race as seen in animal experimentation for medical research. Moreover, the animal welfare view

has been the driving force for animal experimentation which has led many animals such as

rhesus macaques to live painful lives as they are exploited for humans’ needs. However, we must

consider on what basis is it moral for us to take the lives of animals for our own benefit when the

results from experimentations are far less than promising. Furthermore, it is wrong to coerce

animals to undergo experimentation in order for the maximization of profit on the basis of

utilitarianism, suffering, and speciesism. On the other hand, animal models preclinical results can

provide misleading results as several cannot be translated to humans and therefore are poor

predictors of human disease and response to drugs. Ultimately, the only way to end this cruel and

lucrative practice is to abolish animal experimentation and replace it with the alternative methods

such as in vitro testing and in silico (computer) models.

With the help of social pressure resulting from the early Animal Rights Movement, The

Animal Welfare Act was first passed by Congress in 1966 due to the growing concern for the

protection of family pets from thefts. Furthermore, it was not until 1985 that the Animal Welfare
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Act incorporated the Improved Standards for Laboratory Animals Act along with principles of

humane experimentation technique proposed by William Russell and Rex Burch in order to

cause as little distress or pain to the animal, and to replace animal subjects with the use of

alternative methods (Russell & Burch 4). ​Ultimately, this amendment increased the standards of

humane care for animals held in labs such as providing nonhuman primates with an adequate

physical environment that would promote their psychological health (“Public Law 99-198”).

Additionally, it is evident that the Three R’s played a considerable role in this amendment since

it calls for the prevention of the duplication of experiments, reduction or replacement of animal

subjects, and methods that decrease pain and distress (“Public Law 99-198”). Therefore, this act

required researchers to establish I​nstitutional Animal Care and Use Committees that would be

responsible for implementing the Three Rs. To elaborate, the role of these committees are to

review and research specific programs in regards to upholding animal welfare and to inspect

these facilities every six months (Ibrahim 207) . However, as seen with the Silver Springs

Monkey Case and University of Wisconsin’s unethical testing on animals such as the rhesus

macaques has occured on several occasions within the past decade further emphasizing the need

for the protection of animal welfare in cases where the need for medical research undermines the

importance of animal interests.

Although, we cannot deny the genetic similarities between nonhuman primates and

humans it is not enough to justify their use based on the fact that experiments using NHPs have

produced false positives and misleading results that cannot be translated in humans. For

example, the rhesus macaque model was widely utilized by the TeGenero research organization

in order to test the t​herapeutic antibody (anti-CD28 monoclonal antibody TGN1412)​ for cancer
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therapy which was perceived to have promising translational studies (“Failure”). However,

preclinical safety testing in rodents and rhesus macaques failed to predict life threatening

reactions that occurred to six healthy volunteers during the phase I clinical trial of ​anti-CD28

monoclonal antibody TGN1412​. It is important to note that the rhesus macaques were

administered doses of up to ​50 mg·kg–1·week–1 and did not demonstrate ​any adverse side

effects from the therapeutic antibody nor did they show signs of toxicity or systemic immune

stimulation (Eastwood). Thus, this lead researchers to believe that a “humanized antibody”

would produce similar success in regards to its effectiveness. Moreover, once the doses of the

antibody were administered to six healthy volunteers a “Cytokine Storm” unraveled which was

characterized by systemic inflammatory immune response (Eastwood). Furthermore, D.

Eastwood head researcher at TeGenero stated, “​a species difference [between humans and rhesus

macaques] in CD28 expression on the CD4+ effector memory T-cell subset as being most likely

responsible for the failure of preclinical safety testing of TGN1412 in cynomolgus macaques”

(Eastwood).​ It is important to note that this difference in expression affected the applicability of

the model to humans when testing the antibodies. Thus, this demonstrates how the

overestimation of the efficacy of drugs in humans on basis of an animal model’s success is

harmful to the human population even in cases where animals share a large amount of genetic

material. As seen in this study, despite the similarity in genetic material between nonhuman

primates and humans the safety of the antibody was falsely predicted as they failed to determine

that the differences in gene expression would cause harm to six individuals participating in the

clinical trial. With that being said, the use of animal experimentation for medical research

produces isn't as effective as it is it appears or as promoted by medical research industry. Andrew

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C. von Eschenbach, a commissioner of the Food and Drug Administration stated, “Today, nine

out of ten compounds developed in the labs fail in human studies. They fail, in large part because

they behave differently in people than they did in animal or laboratory tests” (Armstrong 314).

Furthermore, Susan J. Armstrong, Professor of Emerita and Environmental Ethics specialist at

Humboldt State University argues, “With its 92 percent clinical failure rate , preclinical animal

testing is an extraordinarily unreliable method of establishing the safety and effectiveness of

pharmaceutical compounds in humans” (Armstrong). Ultimately, flawed designs of experimental

animal and human clinical trials result in unreliable results, a larger financial burden, and the

exploitation of a large number of animal subjects.

Effective alternative testing methods in medical research are shadowed by the

pharmaceutical industry’s agenda which is driven by the maximization of profits in the medical

industry. This is due to the United States government’s budget of an average of $140 billion each

year for scientific research prompts several (Doss 158). Kay Pegg an associate of the Oxford

Centre for Animal Ethics argues​ that, “Research establishments, scientists, regulators and

persons that inspect laboratories for compliance, those associated with granting licences,

companies that sell nonhuman animal subjects and that supply equipment for the research, and

corporations that market the resulting products” are the stakeholders that rely on this industry for

profit maximization (Peggs). The United States’ capitalist system itself has a large impact on the

pharmaceutical industry as it “ ensures that the human health industry not only redefines benefits

as profits and promotes profits ​over​ human beings, it makes profits ​from​ the use of nonhuman

animals” (Peggs). Therefore, pharmaceutical companies are able to justify the conduction of the

experiments by exploiting the idea of the impact that their research and resulting products have
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on human welfare. In fact, the American Medical Association denounced drug companies in

United States for ​spending $4.5 billion on marketing ploys targeting consumers which led an

increase in spending on prescription drugs by 13% and up to an average of $374 billion within

the year (“The Animal”). On the other hand​, grants from organizations like the National Institute

of Health play a prominent role in motivating researchers such as those in academia to conduct

experiments by any means in order to obtain grant money despite the negative consequences

nonhuman animals experience. Through the conduction of animal experiments help these

individuals secure employment at universities seeking to receive these large research grants in

order to aid the prestige of the institution (Peggs). These institutions along with other

organizations are able to collect grants from private sources such as the Bill and Melinda Gates

Foundation which was named by the Foundation for Biomedical Research as one of the largest

supporters of animal research by awarding grants to eligible projects using animal models for

research (“Foundation”). Furthermore, according to public data provided the Bill and Melinda

Gates Foundation the foundation has awarded grants in 2018 ranging from four hundred dollars

to five million dollars to organizations researching vaccine developments, HIV, tuberculosis, and

malaria (“Awarded”). Ultimately, despite the fact that several of these experiments are not

producing viable results they are continued due to the possibility of institutions receiving

incentives in forms of grants (Doss 158-161). Therefore, it is evident that despite the fact that we

are capable of utilizing effective alternative research methods greed drives the exploitation of

innocent animals.

Animal experimentation is morally wrong on the basis of utilitarianism, speciesism, and

suffering. Peter Singer, Professor of Bioethics at Princeton University, built the foundation on
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the morality of the human race’s actions towards animals by stating “self-interest should guide

no morality” (​Practical ​69). Thus, as humans we should stray away from our usual actions that

are rooted in self-interest and orient our actions towards those that would hold other’s interests in

consideration as much as their own. This prompts the idea of the “species” which “allows the

interests of his own speciesism to override the greatest interests of his own species to override

the greater interests of members of other species” (​Animal ​9). Although, many critics have posed

counterarguments to this view on the basis that animals do not hold the same capacities such as

intelligence as human beings it is morally wrong that as humans we justify our actions based on

the belief that our need for innovations surpasses the interests of nonhuman animals. The idea

that humans are dominant over nonhuman animals is congruent with the idea of speciesism

because historically the human race has been willing to perform cruel and painful experiments

for the purposes of medical innovations. Moreover, Singer asserts, “No matter what the nature of

the being, the principle of equality that its suffering be counted equally with the like of

suffering...of any other being” (​Animal​ 9). It is important to note that because humans and

nonhuman animals share the ability to suffer they should be granted equal moral consideration.

Thus, as we continue to face this debate on the morality of animal experimentation we should

consider the utilitarian view which is defined as “a cost-benefit analysis in order to create the

most favorable situation for as many subjects as possible” (Marie 90). Ultimately, through this

principle we can determine morality on the basis of what actions benefit the greater good as a

whole. Thus, through this approach to morality we ponder the extent to which our practice of

animal experimentation takes into account the interests of animals considering that through an

animal rights stance the humans needing the medical innovations can be considered a minority
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group due to the poor rates of success in animal models which cannot prevent inevitable deaths.

Prompting us to question why we are willing to end several nonhuman animal lives for

experiments that have not produced feasible results and that can be replaced with alternative

testing methods.

Although animal experimentation advocates have argued for the benefits and value of

animal experimentation for medical research they fail to acknowledge innovations in technology

such as in vitro and in silico testing which have proven to be suitable alternatives to animal

experimentation. Ultimately, scientific research has found that animal models are not always

efficient in medical research and that alternative methods of testing are useful for conducting the

same experiments without harming animals. Thus, this prompts the idea that animal

experimentation must be abolished as it is the only way to prevent further suffering as a result of

its inefficiency and the Animal Welfare Act inability to protect the welfare of laboratory animals.

Figure 2. Alternative testing methods for animal experimentation in different areas of

medical research provided by ​Science Direct​.

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Animal experimentation should be abolished in the United States and fully replaced with

alternative testing methods that are humane, effective, cheaper, and relevant to humans in

regards to its applicability. As seen in Figure 2, fields such as Chemistry, Physics, and Computer

Science can utilize alternatives to animal experimentation for the purposes of medical

innovations. Our modern science revolution has allowed us to develop technology prompting the

production of effective tools such as in vitro testing and computer (in silico) modeling which can

used for the prediction of effectiveness of medicine and toxicity while eliminating the need for

animal experimentation.

Figure 3. Cost comparison between animal versus in vitro testing provided by the ​Humane

Society​.

The pharmaceutical drug process is a long and expensive process that continues to utilize

animal models to determine drug candidates efficacy, safety, and toxicity despite its lack of

results. According to the Humane Society International animal test on average span from months

or years in order to collect an adequate amount of data which can cost up to two to four million

per two-species lifetime during a study (Humane Society). With that being said, the significant

cost comparison of genetic drug toxicity testing in animal and in-vitro modeling can be observed

in Figure 3. It is important to note that cardiotoxicity is major challenge faced by the drug
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development process as it can lead to withdrawal or adverse effects on the human population

such as ​pro-arrhythmic cardiotoxicity (Passini). Therefore, a major issue in the medical industry

is the ability of animal models results to be translated in humans in regards to disease and

efficacy as several of these “necessary” studies are hindered by publication bias followed by a

lack of systematic review. However, in vivo testing or animal model experiments is currently

required in the by the U.S Food and Drug Administration for determining drug safety before

human clinical trials can begin (Commissary). Moreover, these discrepancies in results and cruel

practice can be replaced by innovation of technology in in-vitro testing and in-silico modeling

which have proven to be effective in modeling human physiology and drug efficacy.

In vitro testing methods are humane and more effective than animal models because they

can mimic the complexity of the structure and functioning of the human organ system in disease

and drug efficacy. It is important to note that in vitro testing is characterized by experimental

testing that utilizes cells or tissues grown in laboratories which are contained in test tubes in

order to uncover any ​toxic properties that may be present in compounds and mixtures ​(Humane

Society; Quinn). The Wyss Institute at Harvard University has revolutionized in vitro testing

through the production of “organs on chips” containing human cells which model the structure

and function of the organ systems of humans eliminating the need for animal models in disease

research, toxicity testing, and drug responses (PETA). Furthermore, these “organs on chips” are

useful because they have the “ability to host and combine the different cell and tissue types

making up organs…[and] mimic human-specific disease states, as well as identify new

therapeutic targets in vitro” (Wyss). Thus, this technology allows for a more accurate

representation of disease and effects on the human body. Moreover, to get a better understanding
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of how the organ systems in the human body are interconnected researchers have developed a

way to link the chips in order to get a holistic understanding of the experimental process itself

(Wyss). A recent study conducted by the Wyss Institute found that the Lung-On-Chip

Microdevice can model pulmonary edema in the lungs, mimic drug toxicity induced by

interleukin-2 (IL-2) pulmonary edema in preclinical cancer patients, and led to the discovery of

biomarkers such as ​angiopoietin-1 (Ang-1) which plays an important role in predicting the

toxicity of the drug on the microdevices​ (Leslie). In addition, the microdevices successfully

identified how the development of vascular leakages leading to pulmonary edema were produced

due to the toxicity of the IL-2 therapy . Overall, researchers found that lung-on-chip model

“​effectively reproduces the intra-alveolar fluid accumulation, fibrin deposition, and impaired gas

exchange that have been observed in living edematous lungs after 2 to 8 days of IL-2 therapy in

humans” (Leslie). As a result, the lung-on-chip model proves to be an effective alternative

method of testing drug toxicity as it was able to mimic clot formation and pulmonary vascular

leakage at similar doses and time scales to those observed in the preclinical studies on cancer

patients(Leslie). Furthermore, the success of the lung-on-chip model in translational studies can

allow for drug efficacy testing in clinically relevant models that are humane, accurate, and

cheaper. On the other hand, t​his industry is projected to grow as researchers at Harvard

University are in the process of further innovating the technology to develop human stem cells

that are capable of differentiating on chips (Wyss). Thus, the applicability of vitro testing not

only demonstrates growth but offers a more humane and applicable model of human disease that

eliminates the need for animal models as seen in the Wyss Institute's pulmonary edema-on-chip

model.
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On the other hand, computer (in silico) modeling is cheaper and more effective because it

demonstrates higher accuracy than animal models in predicting clinical cardiotoxicity. As

mentioned before, the prediction of cardiotoxicity is crucial for the drug development process as

it is often fatal. Elissa Passini, researcher of the Computational Cardiovascular Science Group at

the University of Oxford, elaborates on the findings, “the ability of in silico drug trials in

populations of human action potential (AP) models to predict clinical risk of drug-induced

arrhythmias [is] based on ion channel information,​ and to compare simulation results against

experimental assays commonly used for drug testing” (Passini). Furthermore, through

repolarization abnormality data in silico was able to successfully predict clinical risks in all 62

compounds with an accuracy of 89% as opposed to an accuracy of 75% in the testing of 64 using

rabbits as animal models (Passini). As mentioned before, translational applicability between the

animal models and humans is necessary as the early prediction of adverse effects such as

cardiotoxicity which can be fatal in humans. Thus, it is important to note that a wider distribution

of compounds can be tested by in silico modeling as seen in Oxford University’s study that was

able to test 62 compounds using their human AP models to predict pro-arrhythmic risk while

demonstrating consistent results with electrophysiological recordings in animal models that are

currently utilized in assessing drug safety (Passini). Overall, in silico modeling is human and

more effective in translating drug efficacy results to humans and should replace animal testing.

Despite the data supporting the effectiveness of alternative methods provided throughout

the conduction of this essay, it is imperative to discuss the stigma surrounding the abolishment of

animal experimentation as individuals argue that animal experimentation is ethical and needed

for medical research as it provides us with valuable information. George Poste, veterinarian and
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head of the Biodesign Institute at Arizona State University, argues that animal research is

necessary on the basis that “opposition to all animal testing would require a life without drugs,

vaccines, painkillers, anaesthetics, and surgery” (Poste). Poste pushes his argument on the basis

that all of these innovations could not be used or improved without animal testing because the

U.S Food & Drug Administration would reject them without the use of models to support drug

efficacy. It it is important to recognize that the U.S Food and Drug Administration does not test

drugs developed before approving them. Instead, drugs are approved by FDA “experts” that

conduct a comprehensive review of the lab, animal, and human clinical testing trials composed

by the drug manufacture . Then, the FDA grants approval on the basis that “the agency has

determined that the benefits of the product outweigh the known risks for the intended use”

(Commissary). Furthermore, animal experimentation is necessary as animal models has provided

us with antibiotics, vaccines, and medical treatment that exists in our modern day

Supporters of animal experimentation have argued that using animal models for medical

testing is ethical on the anthropocentric principle that human needs surpass those of animal

subjects. The Foundation of Biomedical Research, a non-profit organization argues that animal

experimentation is justifiable because “​It is not ethical for researchers to test new treatments on

people before they have been tested and researched with lab animals...the U.S. Food and Drug

Administration (FDA) outlaws clinical drug trials in people that have not first been tested in

animals​” (“Frequently”). Thus, animal experimentation is justified because it is responsible for

all our medical innovations and we should continue to conduct experiments that benefit human

welfare.
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Despite, the pro-vivisection stance that calls to promote animal experimentation on the

basis of human health it fails to address the lack of ethics in publication bias and systematic

review in testing that disguises the failure rates of animal models. First and foremost, it is

important to note that publication bias plays a large role in misinforming individuals on the

effectiveness of animal research as seen in a study conducted by Emily S. Sena, researcher at the

Centre for Clinical Brain Sciences which “ identified 16 systematic reviews of animal studies of

acute ischaemic stroke involving 525 unique publications” that failed to account for publication

biases in their studies. Additionally, Sena found that “ publication bias might account for around

one-third of the efficacy reported in systematic reviews, with reported efficacy falling from

31.3% to 23.8% after adjustment for publication bias” (Sena). Through the conduction of a meta

analysis study of animal models in human disease Sena found that out of the seventy one studies

identified only “six reported testing for the presence of publication bias…[Meanwhile]

publication bias was reported in four. No study gave quantitative estimates of the impact on

effect size of publication bias” as seen in Figure 4.

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Figure 4. The lack of accountability of publication bias in a meta analysis study conducted by

Emily S. Sena demonstrating the drastic effects of the over assumption of the efficacy of animal

models of disease.

The failure of these studies to publish data from clinical trials is controversial and unethical as it

provides the public with information on animal model efficacy that is misleading. Therefore, the

presence of publication bias in animal model research is unethical as it harms society by

promoting the spread of false information about the effectiveness of animal models of human

disease.

In conclusion, the use of animal models in medical research are ineffective, inhumane,

and driven by the maximization of profit. As scholars of the twenty first century, it is our

responsibility to raise awareness about this lucrative and exploitative practice as it is morally

wrong for us to conduct these experiments when humane and effective alternatives exist. As an

audience are we finally willing to accept that animal experimentation is cruel and the only

humane resolution we can come to terms with is that the best way to prevent further suffering is

to abolish animal experimentation?

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